Med Business World

Your source for healthcare business

Pharmacy Innovation

The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis

CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that The New England Journal of Medicine (NEJM) has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an…

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting…

PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE:…

Jacobio Announces China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor Plus KRAS G12C Inhibitor

Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor…

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12…

Dragonfly Announces Clinical Collaboration Exploring Combinations Between Dragonfly’s DF1001 HER-2 TriNKET® and Gilead’s Trodelvy® in Two Cancer Indications

Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune activating device developed using Dragonfly’s TriNKET technology platform and Dragonfly’s lead clinical asset, with Trodelvy,…

United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from…

Avicanna Obtains Its First Indication-Specific Drug Registration with Trunerox™

Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the Company’s first indication-specific drug registration for Trunerox™ issued by…

Numab Therapeutics and Ono Pharmaceutical Announce an Option and Collaboration Agreement to Develop Multi-specific Antibody NM49 for Treatment of Cancer

Numab Therapeutics AG (“Numab”) and Ono Pharmaceutical Co., Ltd. (“Ono”) today announced a global research, development and commercialization collaboration for NM49, a multi-specific antibody designed to activate tumor associated macrophage phagocytosis for the treatment of cancers and identified through Numab’s proprietary…

Invitae Files for Voluntary Chapter 11 Protection; Pursues Sale Process

Invitae (OTC: NVTA), a leading medical genetics company, announced today that it is building on previous actions to manage costs and improve its business structure by filing for voluntary chapter 11 protection in the U.S. Bankruptcy Court for the District of New…